Introduction
The Pharmaceuticals and Medical Devices Agency (PMDA) will organize the “PMDA-ATC GMP Inspection Seminar 2026” for overseas regulators engaged in GMP inspections of pharmaceuticals. The seminar will be held IN PERSON in Tokyo, 15 to 17 September 2026. A capacity building seminar for GMP inspections, it is aligned with PIC/S training program, therefore, participants can also expect to experience a pre-learning of the 2026 PIC/S Seminar in Istanbul. Applications from both newcomers and previous GMP inspection seminar alumni are welcome.
We welcome applications from many regulatory authorities. Please note that it is closed to industry and non-regulatory authorities.
Key Seminar Objectives
- To build a shared understanding of PIC/S GMP Annex 22 (Artificial Intelligence) guidelines draft among participants, through information sharing and discussions on the application of advanced technologies in pharmaceutical manufacturing.
- To support participants in developing a good understanding of regulations on GMP inspections, especailly with the following perspectives:
- Advanced technologies in pharmaceutical manufacturing
- GMP inspection reliance in Asia
- To enhance the inspection capacity of participating authorities, thus improving the GMP system of participants' own countries/regions
- To explore the future of pharmaceutical manufacturing by discussing advanced technologies and GMP inspection reliance.
Who should apply
Regulators ONLY (Intermediate level)
- Employees of regulatory authorities with solid working experience of onsite GMP inspections, e.g. having led GMP inspections at a minimum of 5 different manufacturing sites of pharmaceutical products.
- GMP inspectors with over 3 years' experience working in a GMP regulatory department, with the requisite intermediate knowledge of GMP regulations.
- Participants with an ability to readily communicate in English; English will the the medium for lectures and discussions.
- Those with an enthusiasm for discussing advanced technologies and GMP inspection reliance in Asia is required.
Dates / Time
- September 15 (Tuesday), 2026 : 10:00 to 18:00 JST (UTC+9)
- September 16 (Wednesday), 2026 : 10:30 to 16:40 JST (UTC+9)
- September 17 (Thursday), 2026: 10:30 to 12:00 JST (UTC+9)
Program (subject to change)
See the attached program [112KB]
Participants/Applications
To apply for the seminar, please make sure to complete all necessary items on the application form, including the form with the signature by the applicant's head of the organization, before the closing date. Click the link to register: https://www16.webcas.net/form/pub/pmda-atc/gmp26
Registrations close: 16 June 2026
Number of participants: approx. 25
- Selection of participants will be at the discretion of PMDA.
- Confirmation of registration and additional information will be sent to the invited participants after the application closing date.
Others
- All participants should study designated material before participating in the seminar.
- All participants need to answer an obligatory survey about advanced technologies and GMP inspection reliance well before participating in the seminar.
- Materials will be provided electronically. Participants are asked to bring their own personal computers to access these materials as needed.
Fee
There is no registration fee for this seminar.
- Information on travel and hotel reservation assistance will be announced to the approved participants.
- International travel insurance is not covered by PMDA; PMDA strongly recommends participants to purchase a plan before departure.
Seminar Venue
Tokyo, Japan
Contact Us
For more information, please contact:
Secretariat, PMDA-ATC (Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs)
E-mail: PMDA-ATC[at]pmda.go.jp
(Note: For security, e-mail address' @ are replaced with [at]. Please replace [at] with @ to send e-mails to us.)
Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan